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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022227
Receipt No. R000022145
Scientific Title Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery
Date of disclosure of the study information 2016/05/09
Last modified on 2016/05/06

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Basic information
Public title Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery
Acronym Biological responses after usage of open and closed system cardiopulmonary bypass
Scientific Title Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery
Scientific Title:Acronym Biological responses after usage of open and closed system cardiopulmonary bypass
Region
Japan

Condition
Condition valvular heart disease requiring valve replacement or valve plasty
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate differences in biological reactions between an opened-fashion and a closed-fashion cardiopulmonary bypass circuit system in adult patients who undergo cardiac valve surgery
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. length of ICU stay
2. length of postoperative mechanical ventilation
Key secondary outcomes 1. postoperative WBC count
2. postoperaitve hemoglobin and hematocrit
3. postoperative serum creatinine
4. postoperative serum ASL/ALT
(1-4;maximum value within 2 days of surgery)
5. postoperative acute kidney injury (assessed with AKIN classification)
6. intraoperative bleeding


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A total 24 patients consist of the study population. These 24 patients are prospectively divided into the CS-CPB group and OS-CPB group in double blind fashion. Then, the patients will undergo cardiac valve surgery using either open system or closed system cardiopulmonary bypass. Blood collection is performed at four time points, before starting CPB, immediately after surgery, and 24 and 48 hours after surgery. In each time point, the following data are measured; white blood cell, hemoglobin, hematocrit, platelet, serum creatinine, serum AST, serum ALT. Length of postoperative mechanical ventilation, ICU stay, occurrence of AKI, and intraoperative bleeding are investigated in each group.
Interventions/Control_2 A total 24 patients consist of the study population. These 24 patients are prospectively divided into the CS-CPB group and OS-CPB group in double blind fashion. Then, the patients will undergo cardiac valve surgery using either open system or closed system cardiopulmonary bypass. Blood collection is performed at four time points, before starting CPB, immediately after surgery, and 24 and 48 hours after surgery. In each time point, the following data are measured; white blood cell, hemoglobin, hematocrit, platelet, serum creatinine, serum AST, serum ALT. Length of postoperative mechanical ventilation, ICU stay, occurrence of AKI, and intraoperative bleeding are investigated in each group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Those who undergo elective cardiac valve surgery in the Saitama Medical Center, Jichi Medical University, Saitama, Japan
Key exclusion criteria 1) patients aged 49 years or younger
2) patients aged 76 years or older
3) patients who undergo surgical concomitant coronary artery revascularization or thoracic aortic surgery
4) patients who have preoperative liver dysfunction (AST > 30 IU/l and ALT > 30 IU/l)
5) patients who have chronic kidney diseae (serum creatinine level > 2.0mg/dl)
6) patients who have autoimmune disease
7) patients who are treated with steroid or other immune suppressing drug
8) patients who have blood disorder
9) patients in whom preoperative informed consent is difficult
10)patients who have decreased left ventricular function (left ventricular ejection fraction < 40%)
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name NAOYUKI KIMURA
Organization Saitama Medical Center, Jichi Medical University
Division name Cardiovascular Surgery
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama, 330-0834, Japan
TEL +81-48-647-2111
Email kimura-n@omiya.jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Kimura
Organization Saitama Medical Center, Jichi Medical University
Division name Cardiovascular Surgery
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama, 330-0834, Japan
TEL +81-48-647-2111
Homepage URL
Email kimura-n@omiya.jichi.ac.jp

Sponsor
Institute Saitama Medical Center, Jichi Medical University, Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Saitama Medical Center, Jichi Medical University

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 06 Day
Last modified on
2016 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022145

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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